Facility

LEMAITRE VASCULAR, INC.

4 recall(s) on record — most severe on record: Class II.

Key facts

4recalls · worst Class II

3inspections · worst OAI

1warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1000121696
Establishment type	Manufacture Medical Device
Location	206 NORTH CENTER DR. N Brunswick, NJ, US 08902
Registration status	Active · expires 2026
Parent company	LeMaitre Vascular, Inc. (owner-operator 9006148)
Brand names	Artegraft Collagen Vascular Graft; Artegraft Bovine Carotid Artery (BCA); Artegraft Vascular Graft

Activity by year

Recalls (4)
Inspections (3)
Warning letters (1)

Devices registered here (1)

Tissue Graft Of 6mm And Greater
Product code LXA (opens in a new tab) · Class III · Unknown

Recalls & enforcement

Class IIOngoing2026-02-10
Labeling mix-up resulting in the incorrect lot outer packaging of product.
Class IIOngoing2025-09-25
The device was incorrectly packed in the wrong size labeled outer packaging.
Class IIOngoing2025-09-02
The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.
Class IIOngoing2025-08-25
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.

FDA inspections (3)

OAI2025-04-16
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2023-04-13
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2018-02-16
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Warning Letter2025-08-11
Warning Letter (opens in a new tab) · North Brunswick New Jersey

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by LeMaitre Vascular, Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “LEMAITRE VASCULAR, INC. (FEI 1000121696) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000121696-lemaitre-vascular-inc/

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